www.fdanews.com/articles/198998-appili-submits-protocol-for-phase-3-covid-19-trial-of-favipiravir-to-fda
Appili Submits Protocol for Phase 3 COVID-19 Trial of Favipiravir to FDA
September 14, 2020
Canadian drugmaker Appili Therapeutics said it has submitted a new protocol to the FDA for a phase 3 U.S. trial of its influenza antiviral favipiravir as an outpatient treatment for COVID-19.
The study will evaluate the drug’s safety and efficacy for treatment of mild-to-moderate COVID-19 and assess whether it can shorten recovery time and keep infections from progressing to more serious illness.
Appili plans to begin recruiting for the trial this fall. It aims to enroll 826 patients, who will either receive the drug or a placebo.